Post-Approval Monitoring & For-Cause Audits

Post-approval monitoring and/or for-cause audits provide internal oversight on compliance issues relating to the conduct of human subject research on behalf of the Northwestern University Institutional Review Board (IRB). All active human subject research studies under the purview of the Northwestern University IRB can be chosen for review.

Post-Approval Monitoring

Post-approval monitoring is a routine compliance review of the study documents and/or the observation of the consent process. Studies are selected for monitoring according, but not limited to, the following criteria:

  1. Risk level of the study.
  2. Studies involving investigational new drugs (INDs) or devices (IDEs).
  3. An investigator-held IND/IDE.
  4. Studies enrolling vulnerable populations.
  5. Studies requiring more than annual review by the IRB.
  6. Randomly selected from active studies in eIRB.

For-Cause Audits

For-cause audits are not a routine compliance review and are usually triggered by the following events:

  • Participant Complaint
  • Employee Complaint
  • Whistleblower
  • IRB request due to new information that might affect the rights and welfare of research participants

Overview of the Review Process

The IRB will contact the Investigator and study coordinator via e-mail and ask for the following: availability of the PI and study staff and an allocation of resources, such as files, space, and/or access to electronic records. On the day of the review, the study file(s) will be reviewed and interviews may be conducted with study staff.

Preparing for a Monitoring or Audit Visit

Upon completion of the review, a meeting with the PI and study team will be held regarding next steps. A final report is submitted to the PI and study team. If there are findings that need to be reported, then that report along with a response is submitted to the NU IRB for review and consideration via a Reportable New Information submission in eIRB+.

Additional Regulatory Resources